Questions about new health AI rules

Programming Note: Okay, I’ll be off on vacation next week, but will be back to my normal schedule on Tuesday, January 2nd.

Megan R. with wilson

ai reg reaction As Bain reports, new HHS rules are set to take effect in 2025 that will require artificial intelligence developers to explain how their algorithms work.

There is support in the industry, but Pulse also heard skepticism about how effective the rules could be and questions about liability and scope.

Back story: The Office of the National Coordinator for Health IT last week unveiled sweeping rules for AI used in most hospitals and doctors’ offices. In short, the ONC rules will require software developers to provide more data to customers to help providers determine whether AI products are fair, reasonable, lawful, effective, and safe.

feedback: Prominent groups including the Coalition for Health AI, which has members including Google, Microsoft and Duke Health, praised the rules.

It’s really important to enforce some standards, Michael Pencina of Duke AI Health and co-founder of the coalition told Pulse. For the most part, they found the right balance about keeping things moving but not being overly directive.

Agency Conversation: Still, there are questions about how ONC and the FDA, which also regulate AI-enabled medical devices, will work together. Sybil Rohrenbach, executive director of the AI ​​Healthcare Coalition, told Pulse that she would like ONC to treat products already regulated by the FDA differently.

The FDA’s investigation should mean something, Rohrenbach said.

ONC said in its ruling that it worked with the FDA to align the rules to reduce the compliance burden for AI developers covered under both agencies’ rules.

liability: The reliance of ONC rules on individual physicians to make the call about the reliability of AI also raises liability concerns, Rohrenbach said. ONC said they were outside the scope of its rules.

If a medical device fails, we know how to move through that process, Andrew Tomlinson, director of regulatory affairs at the American Health Information Management Association, told Pulse. We have to adopt the same process for AI also.

And Rohrenbeck said she has received many questions about which algorithms the rules apply to, and she hopes for more clarity.

The agency said the scope of the rule is broad, including models that are not directly involved in clinical decision making that could impact care delivery, such as aiding supply chains.

An ONC spokesperson said the agency appreciates and welcomes the strong public response.

Welcome to our final edition of Pulse of 2023. Thank you for your readers, feedback and suggestions throughout the year! Will be back in 2024. Please keep sending your suggestions, ideas and feedback [email protected] And [email protected] And follow @chelseaciruzzo And @_benleonard ,

today on us pulse check podcast, Host Chelsea Siruzzo spoke with POLITICO health care reporter Daniel Payne about how artificial intelligence is already being used across the medical landscape and how regulators are responding.

Grill Lobbies UP As Megan reports, cancer diagnostics company Grail has added to its lobbying roster in Washington and hired high-powered lobbying firms BGR Group and Williams & Jensen to work on issues including Medicare coverage for multiple cancer detection tests. Is hired.

At BGR Group, Grail is former top health aide to ousted chairman kevin mccarthy (R-Calif.) Ryan Long in its corner. According to the disclosure, he is providing strategic advice to the company and advocating on issues related to oncology and multi-cancer diagnostics and screening.

Long, who left Capitol Hill in October, has a one-year cooling off period during which he cannot lobby any members or staffers in leadership offices, but has confirmed that he will lobby for the House and Senate, in addition to the Biden administration. The remaining members are free to advocate. ,

Alec Armanda, who most recently served as a Medicare staffer for Republicans on the House Energy and Commerce Committee, is among those lobbying on the Williams and Jensen contract. The disclosure form said the firm will work on a pair of bills that would allow Medicare to cover tests produced by Grail. Armanda joined the firm last month. He did not respond to a request for comment.

Biotech giant Illumina, which bought Grail in 2021, announced earlier this week that it would divest from the company after years of fighting with antitrust regulators over the deal. According to recently released lobbying disclosures, the two companies’ work for Grail began on December 1.

As Congress prioritizes bipartisan legislation that helps ensure Medicare has the authority to cover multi-cancer early detection tests, Grail continues to educate on the science and work on access barriers to cancer screening. Does, a company spokesperson said in an email.

eyes on the prize Lobbyists from business and consumer groups are planning multiple calls and meetings with lawmakers and staff in the first weeks of 2024 in hopes of forcing stricter disclosure requirements on insurers, pharmacy benefit managers, hospitals and other health facilities that make ad purchases. are considering. , Megan reports.

We were going to take time off so members and staff could enjoy time with their families, but it won’t be long before we get back to Washington to start listening to us again, said Adam Buckalew, who represents a better solution for healthcare. One lobbyist, a coalition that includes AHIP and the American Profit Council.

Earlier this month, the House passed a sweeping health package that would expand Trump-era rules requiring hospitals and insurers to post their prices and negotiate rates for services, and the Senate took up the proposal. Has indicated interest in pursuing further. Lawmakers in both houses have advanced measures that would force pharmacy benefit managers, the intermediaries between drug manufacturers and insurers, to be more transparent about their business operations.

The move is part of a yearlong effort in Congress to address rising health care costs, an issue that could be especially powerful in the 2024 election year.

Naloxone in federal buildings HHS and the General Services Administration, which oversees federal real estate, have updated nearly 15-year-old security guidance saying federal facilities must have naloxone, an opioid overdose-reversal drug, on site.

The updated guidance is based on 2009 recommendations that agencies have automated external defibrillators ready to treat people having heart attacks. The new guidance recommends that AED stations be converted into safety stations that also stock naloxone and items to stop bleeding.

Holiday Respiratory Illness Outlook Nearly 172,500 people went to the emergency room last week for the flu, COVID-19 or respiratory syncytial virus, according to CDC data.

While the agency says the numbers are lower than the same time last year, they also indicate that the respiratory illness season, which typically lasts through the winter months, has not yet peaked.

More than half of ER visits in the week ending Dec. 16 were for flu and a third were for COVID-19, according to CDC data. RSV accounted for about 13 percent of visits. Most of the patients were children under 12 whose seizures had been increasing since October.

Still, vaccination rates remain low, with less than half the population getting a flu shot and less than 10 percent getting the latest Covid shot.

Nursing home residents, a vulnerable population that the CDC has prioritized in its vaccination campaign, have a slightly higher rate: As of Dec. 10, 33 percent of nursing residents had received the latest COVID shot.

Meanwhile, 17 percent of adults ages 60 and older have had their RSV shot.

Government Accountability Office makes five new announcements Health Information Technology Advisory Committee Member: Dr. Lee Fleisher of University of Pennsylvania School of Medicine, Dr. Katrina Parish Of humana, Dr. Randa Perkins of H. Lee Moffitt Cancer Center, Rochelle Prosser Of Orchid Healthcare Solutions And Dr. mark sendak of Duke Institute for Health Innovation.

politician robert king Doctors report on Congress’ decision to leave town without addressing pending cuts in Medicare payments, which could cause new headaches for practices and patients, according to doctor groups that asked CMS for help.

Washington Post Report on shocking rise in colon cancer among young people.

Dr. Zeke Emanuel, Senior Fellow at the Center for American ProgressSTAT explains why health care costs are an exception to inflation.

Clarification: It was not clear in an earlier version of this newsletter whether Alec Armanda had any lobbying restrictions. he doesn’t


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